FDA Approves New Monthly Contraceptive - NuvaRing

American Family Physician,  Dec 1, 2001  by Joanne Chatfield

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The U.S. Food and Drug Administration (FDA) has approved the first monthly vaginal ring for contraception. NuvaRing, a low-dose, combination hormonal device, is self-administered and releases an average continuous dose of 0.120 mg of etonogestrel and 0.015 mg of ethinyl estradiol.

The results of two large clinical trials involving 2,322 women exposed to 23,289 cycles of NuvaRing reported pregnancy rates between one and two per 100 women-years of use. A low incidence of breakthrough bleeding was also reported.

Precise placement of the flexible, transparent ring (measuring approximately 2 inches in diameter and a cross-sectional diameter of 11/48 inch) in the vagina is not critical because it is not a barrier type of contraceptive. After insertion, the ring should be kept in place for 21 consecutive days, removed for seven days, and a new ring inserted at the end of this timeframe. Expulsion of the NuvaRing can occur (e.g., in the presence of vaginal stenosis, cervical prolapse, during removal of a tampon), and the manufacturer advises that no more than three hours elapse without reinsertion. If this timeframe is surpassed, the ring should be reinserted and an additional method of contraception used for seven consecutive days.

Contraindications to NuvaRing include those usually associated with the use of contraceptives. Women who use combination hormonal contraceptives, including NuvaRing, are strongly advised not to smoke. Adverse reactions reported by 5 to 14 percent of clinical trial participants include vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea.

As with other contraceptives, NuvaRing does not protect against human immunodeficiency virus infection or other sexually transmitted diseases.

NuvaRing will be introduced in the United States through the NuvaRing Premier Program through participating physician offices during the fourth quarter of 2001. The consumer phase of the product launch is slated for mid-2002.

To obtain full prescribing information, contact the manufacturer at 800-NUVARING or access the following Web site: http://www.nuvaring.com.

COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group